Effects of High vs. Standard Protein Intake in Newborn Extreme Premature

NCT02478086 | Completed Phase 2 DMC

• 1 other identifier: R-2012-1002-63
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The preterm newborn of extremely low birth weight (PNELW), endures adverse nutritional conditions to mimic intrauterine growth. It´s known that amino acids contribute to protein synthesis, but also intervene in weight gain. Most newborns receive amino acids throw parenteral nutrition at a doses of 3.5gr/k/day, that doses its unable to reach the birth weight when discharged, so the weight its below the 10th percentile, which rises the risk for presenting alterations in neurodevelopment. Objective: To compare a higher doses of parenteral amino acids vs. standard doses, expecting an increased weight gain in the high amino acid doses group, meanwhile following the renal function security profile Methods: A randomize, single blind clinical trial, carried on, in the Neonatology Service of Unidad Medica de Alta Especialidad Numero 48 of the Instituto Mexicano del Seguro Social, in the city of Leon, Mexico. Between the period of 1st August 2012 to 31 January 2013. A standard doses of amino acids was administered (3.5gr) to a control group and a high doses (4gr) to an experimental group. Weight, urea, creatinine and blood urea nitrogen (BUN) were measured weekly. In the study were included all preterm newborns (PN) weighting less than 1500 grs and with less than 32 weeks of gestational age that match all the inclusion criteria. Statics Analysis: descriptive statistics were calculates, also chi2 test and Fisher Exact test were applied to categorical variables, t-student test to continuous variables, and ANOVA in multiple groups.

Conditions

Abnormal Renal Function; Malnutrition

Keywords

amino acids; renal function; extreme premature

Outcome Measures

Primary Outcomes (1)

• Renal function: urea, creatinina and urea nitrogen

  Concerning renal function at 48h after birth and in the subsequent measurements in the 7, 14, 21, 28 day of life, the values of urea, creatinine and BUN, no statistical difference was detected. Also any values outside the reference values in the high dose amino acid group was detected (Table 4).

  at 48h - 28 days

Study Arms (2)

use amine acids parenteral 3.5g

EXPERIMENTAL

Amino acids parenteral (Levamin Nomo 10% ®) Group A with an initial doses of amino acids until reaching 3.5 g/kg/day during 28 days.For the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA. The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

Dietary Supplement: use amine acids parenteral 3.5g

use amine acids parenteral 4g

EXPERIMENTAL

Group B with an initial doses of 2.5 g/kg/day with daily increments of 0.5 g/kg/day until reaching 4 g/kg/day during 34 days.Weight, urea, creatinine and blood urea nitrogen (BUN) were measured weeklyFor the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA. The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

Dietary Supplement: use amine acids parenteral 4g

Interventions

use amine acids parenteral 3.5g DIETARY_SUPPLEMENT

Group A we administered standard doses of amino acids was administered (3.5gr) the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA. The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

Also known as: Levamin Nomo 10% 3.5g / kg / day

use amine acids parenteral 3.5g

use amine acids parenteral 4g DIETARY_SUPPLEMENT

Group B we administered high doses of amino acids was administered (4 gr) the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA. The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet.

Also known as: Levamin Nomo 10% 4g / kg / day

use amine acids parenteral 4g

Eligibility Criteria

• Age: 1 Day - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Preterm infant of less than 32 gestational weeks and weighting less than 1500g

You may not qualify if:

• Preterm infant with severe congenital malformations.
• Patients with acute kidney failure.
• Inform consent form not signed.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator
• Universidad de Guanajuato: collaborator

Study Sites (1)

Instituto Mexicano del Seguro Social

León, Guanajuato, 37200, Mexico

Location

Related Publications (2)

• Moltu SJ, Blakstad EW, Strommen K, Almaas AN, Nakstad B, Ronnestad A, Braekke K, Veierod MB, Drevon CA, Iversen PO, Westerberg AC. Enhanced feeding and diminished postnatal growth failure in very-low-birth-weight infants. J Pediatr Gastroenterol Nutr. 2014 Mar;58(3):344-51. doi: 10.1097/MPG.0000000000000220.

  PMID: 24556755 RESULT

• Kotsopoulos K, Benadiba-Torch A, Cuddy A, Shah PS. Safety and efficacy of early amino acids in preterm <28 weeks gestation: prospective observational comparison. J Perinatol. 2006 Dec;26(12):749-54. doi: 10.1038/sj.jp.7211611. Epub 2006 Oct 5.

  PMID: 17024139 RESULT

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Victor Godinez, Director

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guadalupe Gómez Rodríguez Médico neonatologo

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 23, 2015
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

ME (1)